Grey Haze Over Lake of the Ozarks as Prolift Pelvic Mesh Death Case Begins

It is

grey and 13 degrees F. today in this small town of Camdenton, Missouri as the first day of the Budke v Ethicon defective product case gets underway. The plaintiff in this case will not be here.

Joan Budke, 77, died from her injuries sustained from the Prolift mesh made by J&J's Ethicon division, the plaintiffs contend. Her husband and three adult children are bringing this product liability/ death claim against J&J and a medical malpractice claim against her doctor.

Mesh News Desk will provide coverage in association with The Mesh Warrior Foundation for the Injured and the Sunday Mail, a newspaper in Scotland.

The case was filed by Donald Budke against Johnson & Johnson, Ethicon, Gynecare Worldwide (a division of Ethicon), Becky Simpson, M.D. d/b/a/ Lake Area Women’s Center and Becky Simpson, M.D. of Osage Beach Co. No. 10CM-CC00085, filed in the 26th Judicial Circuit Court, Camden Co. Missouri in July 2, 2014.

Since the plaintiff was first injured in Osage Beach, Camden County, Missouri, that was chosen as the venue for this trial.

The Prolift System was the largest polypropylene pelvic mesh made by Ethicon and was used to hold up sagging pelvic organs. Prolift is particularly difficult to remove because of the many arms used to attach to the body.

Day One Budke case

Attorney Adam Slater said sarcastically he hadn't prepared his opening remarks to the jury. He planned to lay out a very similar case to the $11.1 million Linda Gross trial he had won two years earlier. She too had been implanted with the Prolift System and at the time of her trial had undergone 18 attempts to have the mesh removed. See coverage of the 31-day trial on Mesh News Desk here.

In his opening, Slater thanked the 16 jurors (9 women) for surviving jury selection the day earlier and by applying common sense to this case. “There is only one time for Donald Butke to seek justice,” Slater said gesturing to Donald Budke, an elderly man with a goatee who sat next to two young brunette women.

“You are the most qualified people in the world to be jurors, you are residents of this county, you have common sense, who know right and wrong, you know when someone is not telling you the truth, you know how to listen and decide the facts before you and that’s why you are the perfect person to be on this jury.” ~ Adam Slater.

Slater told the jurors we need to be able to trust what a company tells us in studying, testing and developing their products. Number one should be patient safety but the marketing department at J&J exerted a tremendous amount of influence over marketing and sales. “Unfortunately, doctors who went to work for that company let marketing take control and got swept up in sales and marketing.”

Using a traffic light analogy, Slater said there were warnings that the company “blew through” like running a red light. What were the yellow light warnings the company knew internally?

The Yellow Lights

Slater said internal company documents will show the Prolift mesh had small pores that caused the mesh to shrink and retract, and that a team of European doctors/ consultants to Ethicon warned the pores of the mesh pores needed to be larger. As early as February 23, 2007, a French consultant to Ethicon said “Polypropylene meshes might not be improvable in terms of shrinkage, we may need a completely new material.” ( M. Cosson)

Dr. Michel Cosson, TVM team

Mesh erosions were not uncommon and doctor/consultants to Ethicon had predicted that multiple surgeries to remove mesh would be a “disaster.” Complications would be potentially life changing.

Before it was sold, Ethicon and the group of researchers in France studied a prototype. They set a primary end point to find out whether they should sell the Prolene Soft mesh or not. Prolene Soft had been refashioned from hernia mesh for new applications in a woman’s pelvic floor which the company predicted would yield huge returns. But the results and conclusions showed a failure rate at 12 months and a recurrence rate 26.6 percent. The study did not meet predefined criteria of less than 20 percent. This was the final study report indicating the product did not meet the end point.

“Despite failure they sold it because failure doesn’t mean failure I guess” said Slater.

Gynecare, Prolift (J&J)

Prolift System

Holding a large box containing the Prolift System Pelvic Floor Repair Kit before the jury, Slater peeled back the protective coating, first to the trocars, stainless steel hooks that look like a pirate’s arm. He then uncovered the mesh itself which flopped over the sides of his hand, its arms hanging limp like tentacles.

This was what was used to treat Ms. Budke’s occasional incontinence. “She had a very mild first degree cystocele,” according to her doctor, Dr. Simpson, implying the massive amount of mesh was excessive to treat a condition that could have been resolved with far less mesh in the form of a suture treatment.

“The Prolift System looked snappy but when you put it in the human body it turned out to be a terrible idea because it didn’t work the way they were told it would.”

Jurors in the Budke case will not hear that in mid 2012, Ethicon quietly removed the Prolift and three other meshes from the market citing financial decisions. They will also not hear that the company launched Prolift without even notifying the Food and Drug Administration to the existence of the mesh, completely flying under the radar of the FDA.

Instructions for Use

What appeared in the patient Instructions for Use (IFU) were a world away from what the company was learning about the failures of its Prolene mesh. While Ethicon told the end users- doctors - that Prolene Soft mesh was a revolutionary product, the medical director said the results were middle of the road; the French researchers said the TVM (transvginal mesh) study was a failure; what the company described as a “Transient minimum slight inflammatory reaction” was really a chronic sometimes severe inflammatory reaction; and despite the glossy brochure‘s promises of rare complications, mesh exposure was common and erosion was almost inevitable.

Experimental

The push to market for the Prolift in 2005 was so intense that consultant Dr. Vince Lucente bragged he had the word “experimental” removed from a practice bulletin to doctors presented in the American College of Obstetricians and Gynecologists. Dr. Anne Weber, a urognynecologist and leader in the field had said patients should be told there was limited data to support any other promise. Weber, a urogynecologist who led frequent studies for the National Institutes of Health, was furious when she found out “experimental” had been removed. In doing so, insurance companies could now fund mesh placement surgeries.

Lucente called his move a “total victory” and took credit to Ethicon’s Marketing Director, Price St. Hilaire, an email showed. In response, St. Hilaire wrote, “I am doing the happy dance I love you man !!!!!!!

Joan Budke

In April of 2008, Joan Budke, then 76 years old, was active with her family, her church, her husband and grandchildren. She had a first degree cystocele, or mild urinary leakage. She went to see her doctor, local gynecologist Dr. Becky Simpson, who suggested a mesh implant. Dr. Simpson was a consultant and preceptor (trainer) for Ethicon. She had been instructed on how to use the Prolift by another preceptor, Dr. Vincent Lucente. the surgery took place on April 28, 2008. A TVT-Secur, a sling to hold up the urethra also made by Ethicon, was implanted at the same time.

By July there was a mesh erosion and by January of 2009, Dr. Simpson performed surgery to remove some of the infected mesh. The opening of her ureters had closed from infection and her kidneys were swelling, said Slater. He showed the mesh removed from Ms. Budke on two occasions. It looked like a “V” folded in half and encapsulated with red tissue. “You can see the tissue on it is fibrotic bridging, the pores are completely closed off,” said Slater to the jury. She developed a fistula or infected area between the bladder and vagina and the inflammation was destroying her vaginal wall. Eventually a massive infection led to deep vein thrombosis and a septic emboli that invaded her lung which was resistant to antibiotics. Living on a ventilator, doctors were unable to treat the fungus and bacterial infection in her respiratory system. Eventually Ms. Budke was removed from the ventilator and died August 5, 2009.

Showing a full screen image of the entire family with a smiling Joan Budke at the center, Mr. Budke held a tissue to his face. His eyes were red.

Christy Jones, from Linda Gross Trial 2013. Cameras are not allowed in this Missouri courtroom.

Christy Jones

Around 2: 20 pm, attorney Christy Jones, who has represented Ethicon in numerous trials, started out being defensive and angry. She told jurors she was going to start her opening about Joan Budke but, “I sat over there biting my tongue not to respond to some of the accusation that have been made against J&J and Ethicon.”

Mesh has been used since the 1960s, she said. The French team of doctors took five years to study the Prolene Soft mesh used to make the Prolift. It had an 80 to 90 percent success rate when it was tested in 120,000 women. In randomized controlled trials of 500 women, there were five infections; in another there was one infection.

“There were zero lung infections. Zero!” she said is connecting the dots.

Jones explained the plaintiffs’ contention – that mesh particles had traveled through the body and somehow lodged in the lungs. This threw a confusing curve to the jury because the plaintiff attorney had not clearly explained the connection to pelvic mesh and a lung infection.

By all accounts, Ms. Budke’s April 28, 2008 surgery was a success said Jones. She had no serious problems for eight months - no mesh exposure, no infection. Over a period of time a CT scan showed an abscess in the area of the mesh. “When you have a foreign body like mesh in the body it can do what you heard this morning that is potentiate the infection, it can make it more difficult to treat the infection, not because it causes the infection,” said Jones.

Coincidence

Instead, by mere coincidence, Ms Budke experienced a massive antibiotic resistant autoimmune disease known as to Wegners granulamatosis. “I’ll tell you up front that term does not appear in her medical records. It doesn’t.” See:

http://www.mayoclinic.org/diseases-conditions/wegeners-granulomatosis/basics/definition/con-20028113

Complicating matters- Joan Budke was being treated by dozens of doctors, in three cities and five hospitals. There was not one single doctor coordinating her case, stressed Jones. Sometimes that makes for less than ideal communication. ‘Perhaps that the reason Wegners was never seen" she suggested.

Nor was it treated. The drug of choice for Wegners is a steroid.

“This is going to be a hard case” said Jones lowering her voice so it was barely audible. “Mr. Budke has gone through a hard time and I don’t want anybody in this court including Mr. Budke or his daughters to think we don’t fully appreciate their loss and their grief, and their desire to know what happened. We understand that and I want you to know and I ask you to accept our word that any of our witnesses is meant in any way to minimize their loss and their grief. I mean that sincerely.” #